BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 2940462 · Received December 19, 2012

    Report

    Report Number
    1717344-2012-01259
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 5, 2012
    Manufacturer
    COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED LF1537 WAS RECEIVED FOR EVALUATION AND VISUAL INSPECTION FOUND THE DEVICE WAS THOROUGHLY CLEANED AND DID NOT SHOW EVIDENCE OF USE. THE INVESTIGATION OF THE RETURNED EQUIPMENT DID NOT IDENTIFY ANYTHING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE WAS ACTIVATED ON SIMULATED TISSUE WHILE PRESSING THE BUTTON IN VARIOUS LOCATIONS TO DETECT ANY PROBLEMATIC ACTIVATION ISSUES. THE ROTATION KNOB WAS TURNED TO EACH STOP AND ACTIVATED. FUNCTIONAL TESTING WAS ALSO PERFORMED ON PORCINE KIDNEY TISSUE. MULTIPLE SEALS ON VARIOUS SIZE VESSELS WERE MADE. ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY AND END TONES WERE HEARD INDICATING COMPLETED ACTIVATION CYCLES. THE KNIFE CUT OF THE DEVICE WAS TESTED ON A SILICONE TEST STRIP WITH ACCEPTABLE RESULTS. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADD¿L INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT HAD BLOOD LOSS OF UNDER 500ML, HOWEVER, REGRASP ALARMS WERE HEARD. THE SURGERY WAS EXTENDED BY MORE THAN 30 MINUTES. THE SIZE OF THE VESSEL THAT WAS BLEEDING IS UNK. IT IS ALSO UNKNOWN HOW OFTEN THE DEVICE WAS CLEANED, IF AT ALL, IN THE 30 MINUTES OF USE. THERE WAS NO INJURY TO THE PATIENT AND THE SURGERY WAS FINISHED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON 230625X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK